By DXBMARK
14 regulatory affairs & quality management skills for HealthTech/MedTech: ISO 13485 QMS, MDR 2017/745, FDA 510(k)/PMA, GDPR/DSGVO, ISO 27001 ISMS, SOC 2, CAPA management, risk management, clinical evaluation, and more. Agent skill and plugin for Claude Code, Codex, Gemini CLI, Cursor, OpenClaw.
CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics. Use for CAPA investigations, 5-Why analysis, fishbone diagrams, root cause determination, corrective action tracking, effectiveness verification, or CAPA program optimization.
EU AI Act (Regulation (EU) 2024/1689) operational compliance for compliance teams. Three Article-level decisions: (1) What's the risk tier of this AI system — prohibited (Art. 5), high-risk (Art. 6 + Annex III), limited-risk (Art. 50), or minimal-risk? (2) For high-risk systems, what's the Article 43 conformity assessment route (Module A internal control vs Module H full QMS + notified body) and what goes in the Annex IV technical documentation? (3) Per organizational role (provider / deployer / importer / distributor / authorized representative), what are the active obligations and deadlines? Use during AI system intake review, when planning conformity assessment, or when scoping deployer obligations. Cites Articles + Annexes for every output. NOT executive AI strategy (see chief-ai-officer-advisor). NOT a legal substitute.
FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QSR (21 CFR 820) compliance, HIPAA assessments, and device cybersecurity. Use when user mentions FDA submission, 510(k), PMA, De Novo, QSR, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity.
GDPR and German DSGVO compliance automation. Scans codebases for privacy risks, generates DPIA documentation, tracks data subject rights requests. Use for GDPR compliance assessments, privacy audits, data protection planning, DPIA generation, and data subject rights management.
ISO 27001 ISMS implementation and cybersecurity governance for HealthTech and MedTech companies. Use for ISMS design, security risk assessment, control implementation, ISO 27001 certification, security audits, incident response, and compliance verification. Covers ISO 27001, ISO 27002, healthcare security, and medical device cybersecurity.
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313 production-ready Claude Code skills, plugins, and agent skills for 12 AI coding tools.
The most comprehensive open-source library of Claude Code skills and agent plugins — also works with OpenAI Codex, Gemini CLI, Cursor, and 7 more coding agents. Reusable expertise packages covering engineering, DevOps, marketing (incl. v2.7.3 AEO — Answer Engine Optimization for LLM citation), security (PreToolUse hooks), compliance, C-level advisory (incl. founder-mode CFO/CMO/CRO/CPO/COO/CHRO/CISO/GC/CDO/CAIO/CCO/VPE personas + 21 /cs:* slash commands), productivity (capture/email/reflect), and a complete research stack (litreview/grants/dossier/patent/syllabus/pulse/notebooklm + hybrid router).
Works with: Claude Code · OpenAI Codex · Gemini CLI · OpenClaw · Hermes Agent1 · Cursor · Aider · Windsurf · Kilo Code · OpenCode · Augment · Antigravity
5,200+ GitHub stars — the most comprehensive open-source Claude Code skills & agent plugins library.
Claude Code skills (also called agent skills or coding agent plugins) are modular instruction packages that give AI coding agents domain expertise they don't have out of the box. Each skill includes:
One repo, eleven platforms. Works natively as Claude Code plugins, Codex agent skills, Gemini CLI skills, and converts to 8 more tools via scripts/convert.sh. All ~402 Python tools run anywhere Python runs.
| Skills | Agents | Personas | |
|---|---|---|---|
| Purpose | How to execute a task | What task to do | Who is thinking |
| Scope | Single domain | Single domain | Cross-domain |
| Voice | Neutral | Professional | Personality-driven |
| Example | "Follow these steps for SEO" | "Run a security audit" | "Think like a startup CTO" |
All three work together. See Orchestration for how to combine them.
# Clone the repository
git clone https://github.com/alirezarezvani/claude-skills.git
cd claude-skills
# Run the setup script
./scripts/gemini-install.sh
# Start using skills
> activate_skill(name="senior-architect")
# Add the marketplace
/plugin marketplace add alirezarezvani/claude-skills
# Install by domain
/plugin install engineering-skills@claude-code-skills # 24 core engineering
/plugin install engineering-advanced-skills@claude-code-skills # 25 POWERFUL-tier
/plugin install product-skills@claude-code-skills # 12 product skills
/plugin install marketing-skills@claude-code-skills # 43 marketing skills
/plugin install ra-qm-skills@claude-code-skills # 12 regulatory/quality
/plugin install pm-skills@claude-code-skills # 6 project management
/plugin install c-level-skills@claude-code-skills # 28 C-level advisory (full C-suite)
/plugin install business-growth-skills@claude-code-skills # 4 business & growth
/plugin install finance-skills@claude-code-skills # 2 finance (analyst + SaaS metrics)
# Or install individual skills
/plugin install skill-security-auditor@claude-code-skills # Security scanner
/plugin install playwright-pro@claude-code-skills # Playwright testing toolkit
/plugin install self-improving-agent@claude-code-skills # Auto-memory curation
/plugin install content-creator@claude-code-skills # Single skill
Hermes Agent is BYO-sync tier: the repo ships a pre-generated .hermes/skills/claude-skills/ tree (305 skills across 12 domains as of v2.7.3), but you run python scripts/sync-hermes-skills.py once locally to install into ~/.hermes/skills/. Uses the same agentskills.io SKILL.md standard — no format conversion. ↩
npx claudepluginhub dxbmark/claude-skills --plugin ra-qm-skillsVP of Engineering advisory: delivery throughput analyzer (DORA 4 metrics + cycle-time bottleneck identification), eng hiring funnel calculator (7-stage conversion + pipeline gap + weakest-stage fixes), eng team structure designer (squad/tribe model + manager-trigger + director-trigger + span-of-control). 4 in-depth references: DORA framework, eng hiring funnel, eng team structure (Conway's Law), production discipline (on-call, incidents, deployment, SLOs). Stdlib-only. Standalone-installable; also bundled in c-level-skills. NOT a CTO skill — VPE owns how the team ships, CTO owns what to build.
Chief Customer Officer advisory for startups: retention decomposition analyzer (honest GRR vs NRR + 7-category churn taxonomy), customer segmentation designer (4-tier framework + ICP fit scoring + kill list), CS coverage calculator (pooled vs named CSM models + ratio math + 12-month hiring plan). 4 in-depth references: retention decomposition, customer segmentation strategy, CS coverage model, CS team org evolution (CSM vs Support vs AM vs IM vs CS Ops). Stdlib-only. Standalone-installable; also bundled in c-level-skills. Strategic only - does not duplicate business-growth tactical CS skills.
Chief Data Officer advisory: AI training data audit (origin x class x use-case matrix with GDPR Art. 6 + EU AI Act citations -> GO/MITIGATE/NO-GO per source), data product strategy picker (warehouse vs lakehouse vs mesh + 6-layer build-vs-buy + 12-month sequencing), data asset valuator (strategic value 0-10 + M&A multiplier with carve-out penalties + 3 ranked productization paths). 4 references answering one decision each: training rights, data product strategy, customer-data-as-asset, data team org evolution. Stdlib-only. Standalone-installable; also bundled in c-level-skills. Strategic only - does not duplicate engineering data skills.
Founder-mode executive team plugin: 13 cs-* C-suite agents (CFO, CMO, CRO, CPO, COO, CHRO, CISO, Chief of Staff, General Counsel, Chief Data Officer, Chief AI Officer, Chief Customer Officer, VP of Engineering) plus 21 /cs:* slash commands for forcing-question office hours (incl. /cs:vpe-review), multi-role boardroom deliberation, strategic sprint pipeline, and meta routing. Wraps the 33 c-level skills (including vpe-advisor with delivery throughput DORA analyzer + eng hiring funnel calculator + eng team structure designer) with cognitive gearing and artifact handoffs.
Mid-conversation reflection skill that pauses execution and zooms out from detail-mode to honestly reassess direction, assumptions, and bias. Use when the user says 'reflect', 'take a step back', 'step back', 'zoom out', 'are we missing something', 'bigger picture', 'sanity check this', 'are we on track', 'are we overthinking this', 'forest for the trees', or any variation signaling intent to break out of detail-mode and reassess. Also trigger when the conversation has gone deep on implementation details without strategic check-in, or when the user shows signs of being stuck — that's often a signal the framing needs a reset, not more detail work. Intentionally low-intake: runs the 5-dimension analysis immediately when prior context is rich enough; asks one forcing clarifier only when invocation context is too thin to reassess from.
Lazy senior dev mode. Forces the simplest, shortest solution that actually works: YAGNI, stdlib first, no unrequested abstractions.
Comprehensive skill pack with 66 specialized skills for full-stack developers: 12 language experts (Python, TypeScript, Go, Rust, C++, Swift, Kotlin, C#, PHP, Java, SQL, JavaScript), 10 backend frameworks, 6 frontend/mobile, plus infrastructure, DevOps, security, and testing. Features progressive disclosure architecture for 50% faster loading.
Develop, test, build, and deploy Godot 4.x games with Claude Code. Includes GdUnit4 testing, web/desktop exports, CI/CD pipelines, and deployment to Vercel/GitHub Pages/itch.io.
Tools to maintain and improve CLAUDE.md files - audit quality, capture session learnings, and keep project memory current.
A growing collection of Claude-compatible academic workflow bundles. Covers scientific figures, manuscript writing and polishing, reviewer assessment, citation retrieval, data availability, paper reading, literature search, response letters, paper-to-PPTX conversion, and evidence-grounded Chinese invention patent drafting. Rules are organized as reusable skill folders with explicit workflows and quality checks.
Evidence-gated AI coding workflow: scan → analyze → plan → TDD → execute → fix → verify → review, powered by Codebase Memory MCP >= 0.9.0 with optional Serena LSP intelligence. Includes blast-radius planning, test/cycle gates, independent review, and Windows Git Bash hook auto-resolution.